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Federal Regiater / Vol. 47, No. 167 / Friday, August 27, 1982 / Notices 
pathogens. Dr. Tolin pointed out that 
Klebsiello appears in Sublist A of 
Appendix A and therefore many 
experiments involving Klebsiella will be 
totally exempt from the Guidelines. 
Dr. Holmes suggested that the RAC 
might follow either of two options: (1) 
Recommend Appendix B as proposed by 
the working group, or (2) retain 
Appendix B as it appears in the current 
Guidelines. He said he would suggest as 
an amendment that RAC retain 
Appendix B as it currently appears in 
the Guidelines. Dr. Bems disagreed; he 
said few substantive changes had been 
made m proposed Appendix B, and he 
would not accept Or. Holmes' 
amendment. Dr. Holmes withdrew his 
amendment 
Mr. Thornton called the question on 
Dr. Ahmed's motion to recommend the 
proposed revised Guidelines, as 
amended. By a vote of eighteen in favor, 
none opposed, and no abstentions, the 
motion was accepted. 
Response of Director, NIAID, to tbe 
RAC Recommendations 
In this section. I will review the 
recommendations of the RAC on the 
proposed revised Guidelines. They were 
published for public comment in the 
Federal Register of May 26. 1962. Only 
one comment was received, from Dr. 
)ohn Richardson. Director, Office of 
Biosafety, Centers for Disease Control. 
The comment dealt solely with 
Appendix B of the Guidelines and is 
discussed below under that heading. 
The RAC at its June 28. 1982. meeting 
took the proposed revised Guidelines as 
they appeared in the Federal Register on 
May 2^ 1982. as a starting point. They 
recommended a few additional changes 
which are discussed below, and then 
voted eighteen in favor, none opposed, 
and no abstentions to recommend this 
Guideline revision. 
A. Parts I and ll 
The RAC recommended no changes in 
Parts I and U of the proposed revised 
Guidelines as published in the Federal 
Register of May 26, 1982 (47 FR 23110). I 
accept this recommendation. 
B. Port lU 
In Section lll-B-2-a. the RAC 
recommended deletion of the word 
"viral" in the second sentence which 
read as follows in the proposed revised 
Guidelines: 
Rpcombinani DNA experiments In which 
DNA frtMD Class 4 agents is tranaferred into 
nonpalhogenic prokaryotes or lower 
eukaryotes can be performed at P2 
containment after demonstration that only a 
totally irreversibly defective fraction of the 
agent's v/rof genome is present in a given 
recombinant. (Underlining added.) 
The reason for the RAC's 
recommendation for deletion of the 
word "viral" is that although only viral 
agents are currently classiBed as Class 4 
agents, removal of the speciBcation of 
"viral" would allow for the possible 
introduction of different (ypes of Class 4 
agents in the future. I accept this 
recommendation. 
At the end of Section 111-B 4 a . the 
RAC recommended that language 
should be added regarding the 
requirement for a USDA permit for work 
with Class 5 agents. 1 accept this 
recommendation, and the following 
sentence has been added at the end of 
Section 111-B -4-a: 
A USDA permit is required for work with 
Class 5 agents (18.20). 
At the end of the Brst paragraph of 
Section lU-C, the RAC recommended 
that a reference should be added during 
the reader's attention to the policy 
statement in the Brst two paragraphs of 
Section IV-A. Section Ill-C deals with 
experiments not included in Sections 
III-A, ni-B. or Ill-D. Concern had been 
raised that non-exempt experiments 
which might merit more stringent review 
by RAC or by the IBC prior to initiation 
of the experiment might not be 
adequately described in Sections IIl-A 
and ni-B and. thus, would automatically 
fall into Section lIl-C. The working 
group members requested that the 
language of Section IIl-C be evaluated 
by the RAC in the hope that language 
might be developed to alert researchers 
and (BCs of this possibility. The Brst 
two paragraphs of the policy statement 
in Section IV-A state that the 
Guidelines cannot anticipate every 
possible situation, and that it is the 
responsibility of the institution to adhere 
to the intent of the Guidelines as well as 
to their speciBcs. 
I accept the recommendation of the 
RAC that a reference to the Brst two 
paragraphs of Section fV-A be added to 
Section Ill-C. Accordingly, the following 
wording has been added at the end of 
the first paragraph of Section lIl-C: 
(The reader should refer to the policy 
statement In the first two paragraphs of 
Section IV-A.) 
Other than the changes discussed 
above, the RAC recommended adoption 
of Part III of the proposed revised 
Guidelines as published in the Federal 
Register of May 26, 1982 (47 FR 23110). 1 
accept this recommendation. 
C Part IV 
The RAC recommended changing the 
word "purpose" to "intent" in the last 
sentence of the second paragraph of 
Section IV-A to reflect more clearly the 
meaning of this sentence. 
1 accept this recommendation, and the 
last sentence of the second paragraph of 
Section IV-A has been modified to read 
as follows: 
Therefore, it is the responsibility of the 
institution and those associated with it to 
adhere to the intent of the Guidelines as well 
as to their specifics. 
Under Section IV-B-2-a, I note that the 
RAC recommended accepting the 
proposal of the working group that the 
requirement for nonafBliated 
membership on an Institutional 
Biosafety Committee (IBC) be changed 
to "at least two members" from the 
previous requirement for "at least two 
members (but not less than 20 percent of 
the membership of the committee)." 1 
also note that in Section IV-B-2-b, 
dealing with recommendations for the 
composition of an IBC, the RAC 
recommended accepting the 
modification of item (iii) to read "at 
least one member be from the 
laboratory technical staff." The previous 
version read: "at least one member be a 
nondoctoral person from a laboratory 
technical staff." I accept these 
recommendations. 
At the end of Section lV-C-l-a-(4), 
the RAC recommended addition of a 
reference to a new Appendix ) (See 
discussion of Appendix ] below). 1 
accept this recommendation. 
The RAC recommended deletion of 
the "Note" in Section lV-D-4 which had 
been proposed to read as follows: 
Other Federal agencies which have 
adopted the NIH Guidelines may have the 
authority to terminate funding to their 
grantees should these grantees not comply 
with the NIH Guidelines. 
Instead, the RAC recommended the 
addition of a new appendix (Appendix 
I) to the Guidelines which would have 
information about the Federal 
Interagency Advisory Committee on 
Recombinant DNA Research, and the 
insertion of a reference to Appendix ] in 
place of the "Note." I accept this 
recommendation. A new Appendix ] has 
been added to the Guidelines, and a 
reference to this appendix has been 
added under Section IV-D— 4. 
The working group had recommendeo 
deletion of several sections of Part IV of 
the Guidelines. These deletions were not 
incorporated into the proposed revised 
Guidelines as published in the Federal 
Register of May 26, 1982. NIH staff felt 
that retention of these sections would 
permit greater flexibility in interpreting 
and administering the Guidelines. Those 
sections which the working group 
[ 545 ] 
